FDA 510(k)

MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

K-Number: K012428 · 2001-09-28

Decision Date2001-09-28

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Physio-Control Corp.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012428. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Medtronic Physio-Control Corp.. The 510(k) number is K012428.

When did MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR receive FDA 510(k) clearance?

MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012428.

Who is the listed applicant for MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

The FDA 510(k) record lists Medtronic Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

The FDA product code for MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is MKJ. This falls under the Dental category.

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Other records listing Medtronic Physio-Control Corp. as applicant

K040775LIFEPAK 12 K033275LIFEPAK 12, 20, 500, CR PLUS K022732INFANT/CHILD REDUCED ENERGY ELECTRODES K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER K011144LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR K010918LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM

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Related Devices (Code: MKJ)

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems K131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.